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PURPOSE Despite the growing popularity of stepped-wedge cluster randomized trials (SW-CRTs) for practice-based research, the design's advantages and challenges are not well documented. The objective of this study was to identify the advantages and challenges of the SW-CRT design for large-scale intervention implementations in primary care settings. METHODS The EvidenceNOW: Advancing Heart Health initiative, funded by the Agency for Healthcare Research and Quality, included a large collection of SW-CRTs. We conducted qualitative interviews with 17 key informants from EvidenceNOW grantees to identify the advantages and challenges of using SW-CRT design. RESULTS All interviewees reported that SW-CRT can be an effective study design for largescale intervention implementations. Advantages included (1) incentivized recruitment, (2) staggered resource allocation, and (3) statistical power. Challenges included (1) time-sensitive recruitment, (2) retention, (3) randomization requirements and practice preferences, (4) achieving treatment schedule fidelity, (5) intensive data collection, (6) the Hawthorne effect, and (7) temporal trends. CONCLUSIONS The challenges experienced by EvidenceNOW grantees suggest that certain favorable real-world conditions constitute a context that increases the odds of a successful SW-CRT. An existing infrastructure can support the recruitment of many practices. Strong retention plans are needed to continue to engage sites waiting to start the intervention. Finally, study outcomes should be ones already captured in routine practice; otherwise, funders and investigators should assess the feasibility and cost of data collection. Key words: stepped wedge cluster randomized trial; practice improvement; study design; implementation; qualitative Ann Fam Med 2022;20:255-261. https://doi.org/10.1370/afm.2810, INTRODUCTION As a burgeoning study design in health services research, stepped-wedge cluster randomized trials (SW-CRTs) can have advantages over parallel CRTs in terms of statistical power and offer a pragmatic [...]

PURPOSE We undertook a study to assess whether implementing 7 evidence-based strategies to build improvement capacity within smaller primary care practices was associated with changes in performance on clinical quality measures (CQMs) for cardiovascular disease. METHODS A total of 209 practices across Washington, Oregon, and Idaho participated in a pragmatic clinical trial that focused on building quality improvement capacity as measured by a validated questionnaire, the 12-point Quality Improvement Capacity Assessment (QICA). Clinics reported performance on 3 cardiovascular CQMs--appropriate aspirin use, blood pressure (BP) control ( RESULTS Practices improved QICA scores by 1.44 points (95% CI, 1.20-1.68; P CONCLUSIONS Improvements in clinic-level performance on BP control may be attributed to implementation of 7 evidence-based strategies to build quality improvement capacity. These strategies were feasible to implement in small practices over 15 months. Key words: practice facilitation; high-leverage change; quality improvement; cardiovascular disease; risk factors; preventive medicine; evidence-based practice; clinical quality measure; Healthy Hearts Northwest study; EvidenceNOW; AHRQ; organizational innovation, INTRODUCTION Primary care practices in the United States are in a period of transition, with considerable pressure from payers and policy makers to improve quality of care and reduce costs. [...]

PURPOSE The Trial of Aggregate Data Exchange for Maintenance of Certification and Raising Quality was a randomized controlled trial which first had to test whether quality reporting could be a by-product of clinical care. We report on the initial descriptive study of the capacity for and quality of exchange of whole-panel, standardized quality measures from health systems. METHODS Family physicians were recruited from 4 health systems with mature quality measurement programs and agreed to submit standardized, physician-level quality measures for consenting physicians. Identified measure or transfer errors were captured and evaluated for root-cause problems. RESULTS The health systems varied considerably by patient demographics and payer mix. From the 4 systems, 256 family physicians elected to participate. Of 19 measures negotiated for use, 5 were used by all systems. There were more than 15 types of identified errors including breaks in data delivery, changes in measures, and nonsensical measure results. Only 1 system had no identified errors. CONCLUSIONS The secure transfer of standardized, physician-level quality measures from 4 health systems with mature measure processes proved difficult. There were many errors that required human intervention and manual repair, precluding full automation. This study reconfirms an important problem, namely, that despite widespread health information technology adoption and federal meaningful use policies, we remain far from goals to make clinical quality reporting a reliable by-product of care. Key words: health information technology; quality measures; family physicians; quality indicators; health care; certification, INTRODUCTION Family physicians provide nearly 20% of all clinical outpatient visits, nearly 200 million visits in the United States annually. (1) Frontline clinicians continue to report failures of certified electronic [...]

INTRODUCTION: People enrolled in Medicaid managed care who struggle with diabetes control often have complex medical, behavioral, and social needs. Here the authors report the results of a program designed to partner with primary care teams to address those needs. METHODS: A nonprofit organization partnered with a Medicaid managed care plan and a Federally Qualified Health Center in California to enroll people with A1cs >9% in a 12-month program. The program team included a community health worker, certified diabetes care and education specialist/registered dietitian, behavioral health counselor, and registered nurse. They developed patient-led action plans, connected patients to community resources, and supported behavior changes to improve diabetes control. Baseline assessments of behavioral health conditions and social needs were collected. Monthly A1c values were tracked for participants and a comparison group. RESULTS: Of the 51 people enrolled, 83% had at least 1 behavioral health condition. More than 90% reported at least 1 unmet social need. The average monthly A1c among program participants was 0.699 lower than the comparison group post-enrollment (P = .0008), and the disparity in A1c between Hispanic and non-Hispanic White participants at enrollment declined. DISCUSSION: Participants had high levels of unmet medical, behavioral, and social needs. Addressing these needs resulted in a rapid and sustained improvement in A1c control compared to non-enrollees and a reduction in disparity of control among Hispanic participants. CONCLUSION: By partnering with a primary care team, a program external to Federally Qualified Health Center primary care can improve clinical outcomes for people with complex needs living with diabetes. [ABSTRACT FROM AUTHOR]

PURPOSE We conducted a randomized controlled trial to compare the effectiveness of adding various forms of enhanced external support to practice facilitation on primary care practices' clinical quality measure (CQM) performance. METHODS Primary care practices across Washington, Oregon, and Idaho were eligible if they had fewer than 10 full-time clinicians. Practices were randomized to practice facilitation only, practice facilitation and shared learning, practice facilitation and educational outreach visits, or practice facilitation and both shared learning and educational outreach visits. All practices received up to 15 months of support. The primary outcome was the CQM for blood pressure control. Secondary outcomes were CQMs for appropriate aspirin therapy and smoking screening and cessation. Analyses followed an intention-to-treat approach. RESULTS Of 259 practices recruited, 209 agreed to be randomized. Only 42% of those offered educational outreach visits and 27% offered shared learning participated in these enhanced supports. CQM performance improved within each study arm for all 3 cardiovascular disease CQMs. After adjusting for differences between study arms, CQM improvements in the 3 enhanced practice support arms of the study did not differ significantly from those seen in practices that received practice facilitation alone (omnibus P = .40 for blood pressure CQM). Practices randomized to receive both educational outreach visits and shared learning, however, were more likely to achieve a blood pressure performance goal in 70% of patients compared with those randomized to practice facilitation alone (relative risk = 2.09; 95% CI, 1.16-3.76). CONCLUSIONS Although we found no significant differences in CQM performance across study arms, the ability of a practice to reach a target level of performance may be enhanced by adding both educational outreach visits and shared learning to practice facilitation. Key words: primary health care; cardiovascular disease; quality improvement; chronic illness; prevention; health promotion; quantitative methods; health services; organizational change; practice-based research, INTRODUCTION Past efforts to transform primary care have included practice redesign based on medical home principles and adoption of electronic health records. (1-4) More recently, primary care practices face increasing [...]

Passage of the Patient Protection and Affordable Care Act triggered 2 successive grant initiatives from the Agency for Healthcare Research and Quality, allowing for the evolution of health extension models among 20 states, not limited to support for in-clinic primary care practice transformation, but also including a broader concept incorporating technical assistance for practices and their communities to address social determinants of health. Five states stand out in stretching the boundaries of health extension: New Mexico, Oklahoma, Oregon, Colorado, and Washington. Their stories reveal lessons learned regarding the successes and challenges, including the importance of building sustained relationships with practices and community coalitions; of documenting success in broad terms as well as achieving diverse outcomes of meaning to different stakeholders; of understanding that health extension is a function that can be carried out by an individual or group depending on resources; and of being prepared for political struggles over 'turf' and ownership of extension. All states saw the need for long-term, sustained fundraising beyond grants in an environment expecting a short-term return on investment, and they were challenged operating in a shifting health system landscape where the creativity and personal relationships built with small primary care practices was hindered when these practices were purchased by larger health delivery systems. Key words: health extension; primary care; organizational change; outreach; population health; social determinants of health; practice-based research, INTRODUCTION Health extension is a model being developed and implemented across the country that was adapted from the agricultural Cooperative Extension Service, which traditionally linked land-grant university resources with rural [...]

PURPOSE Six key elements of opioid medication management redesign in primary care have been previously identified. Here, we examine the effect of implementing these Six Building Blocks on opioid-prescribing practices. METHODS Six rural-serving organizations with 20 clinic locations received support for 15 months during the period October 2015 to May 2017 to implement the Six Building Blocks. Patients undergoing long-term opioid therapy (LtOT) at these study sites were compared with patients undergoing LtOT enrolled in a regional health plan who did not receive care at the study sites but who resided in the same primary care service areas (control group). Outcomes were monthly trend in the proportion of patients undergoing LtOT prescribed a >100 morphine equivalent dose (MED) of opioids daily and the total number of patients receiving an opioid prescription. An interrupted time series using difference- indifference analysis was used for tests of significance. RESULTS The proportion of patients prescribed a >100 MED of opioids daily decreased 2.2% (11.8% to 9.6%) among patients at the intervention clinics and 1.3% (14.0% to 12.7%) among patients in the control group. The rate of decrease was significantly greater among study patients than among patients in the control group (P = .018). The rate of decrease in the number of patients on LtOT at intervention clinics increased during the intervention period compared with the preintervention period (P CONCLUSIONS Efforts to redesign opioid medication management in primary care resulted in a significant decrease in opioid prescribing. Future research is needed to determine if these results are generalizable to other settings and to assess implications for patient-reported outcomes., INTRODUCTION Use of opioid medication long term for chronic pain has contributed to an epidemic of opioid overdose and addiction. (1) Although rates of opioid prescribing have moderated in recent [...]

PurposeWe aimed to advance the internal and external validity of research by sharing our empirical experience and recommendations for systematically reporting contextual factors.MethodsFourteen teams conducting research on primary care practice transformation retrospectively considered contextual factors important to interpreting their findings (internal validity) and transporting or reinventing their findings in other settings/situations (external validity). Each team provided a table or list of important contextual factors and interpretive text included as appendices to the articles in this supplement. Team members identified the most important contextual factors for their studies. We grouped the findings thematically and developed recommendations for reporting context.ResultsThe most important contextual factors sorted into 5 domains: (1) the practice setting, (2) the larger organization, (3) the external environment, (4) implementation pathway, and (5) the motivation for implementation. To understand context, investigators recommend (1) engaging diverse perspectives and data sources, (2) considering multiple levels, (3) evaluating history and evolution over time, (4) looking at formal and informal systems and culture, and (5) assessing the (often nonlinear) interactions between contextual factors and both the process and outcome of studies. We include a template with tabular and interpretive elements to help study teams engage research participants in reporting relevant context.ConclusionsThese findings demonstrate the feasibility and potential utility of identifying and reporting contextual factors. Involving diverse stakeholders in assessing context at multiple stages of the research process, examining their association with outcomes, and consistently reporting critical contextual factors are important challenges for a field interested in improving the internal and external validity and impact of health care research.

Background. Numerous methods have been used to evaluate medication management quality in older adults; however, their predictive validities are unknown. Major medication quality indicators include polypharmacy, drug-drug interactions, and inappropriate medication use. To date, no study has attempted to evaluate the three approaches systematically or the effect of each approach on mortality in a Hispanic population. Our objective was to evaluate file relationship between polypharmacy, drug-drug interactions, and inappropriate medication use oil the mortality of a community-based population of Mexican American older adults. Methods. We used a lid table survival analysis of a longitudinal survey of a representative sample of 3050 older Mexican Americans of whom 1823 were taking prescription and over-the courtier medications. Results. After adjustment for relevant covariates, use of more than four different medications (polypharmacy) was independently associated with mortality. The presence of major drug interactions and the use of inappropriate medications were not significantly associated with mortality in our study sample. Conclusion. Polypharmacy (>4 medications) is significantly associated with mortality in Mexican American older adults. This community-based study is the first to demonstrate a direct association between polypharmacy and mortality in this population.